Incidence of phimosis and paraphimosis in patients treated with SGLT2 inhibitors

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106883
• EU PAS number:
  EUPAS106882
• Study ID:
  106883
• Official title and acronym:
  Incidence of phimosis and paraphimosis in patients treated with SGLT2 inhibitors
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A cohort study aimed at estimating one-year and two-year incidence proportions of phimosis and paraphimosis among individuals who initiated treatment with an SGLT2 inhibitor.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 10/07/2023

Actual: 10/07/2023

Study start date

Planned: 10/07/2023

Actual: 10/07/2023

Date of final study report

Planned: 31/08/2023

Actual: 08/09/2023

Sources of funding

EMA

Study protocol

Initial protocol

Final_Analysis_Plan--Phimosis__Paraphimosis__SGLT2i__Redacted_version_for_publication

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable